BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA NEEDLE DRIVER INSTRUMENT

    MDR report key: 3002461 · Received March 13, 2013

    Report

    Report Number
    2955842-2013-00810
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    January 15, 2013
    Report Date
    February 12, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE INSTRUMENT HAD A FRAYED GRIP CABLE. THE FRAYED CABLE SECTION WAS STICKING OUT AT THE WRIST. THERE WAS NO DAMAGE FOUND ON THE PULLEY. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DAVINCI S SURGICAL PROCEDURE, THE CUSTOMER NOTED THAT WIRES WERE PROTRUDING FROM THE MEGA NEEDLE DRIVER INSTRUMENT. NOTHING FELL INTO THE PATIENT AND NO HARM TO THE PATIENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105722 MEGA NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420194-08 M10120803 358

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SYSTEM, INSTRUMENTS AND ACCESSORIES